Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer

• ClinicalTrials.gov Identifier: NCT04428788
• Recruitment Status: Recruiting
• First Posted: June 11, 2020
• Last Update Posted: April 1, 2024
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

Tracking Information

• First Submitted Date: May 29, 2020
• First Posted Date: June 11, 2020
• Last Update Posted Date: April 1, 2024
• Actual Study Start Date: June 22, 2020
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2023)

• Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria [ Time Frame: From the time of consent at screening until 28 days after thesubject discontinues study treatment. ]
• Dose-limiting toxicity (DLT) [ Time Frame: Up to 35 days ]
• Non-tolerated dose (NTD) [ Time Frame: Up to 35 days ]
• Maximum tolerated dose (MTD) [ Time Frame: Up to 35 days ]

Original Primary Outcome Measures (submitted: June 10, 2020)

• Adverse Events (AEs) [ Time Frame: From the time of consent at screening until 28 days after the subject discontinues study treatment. ]
  Type, frequency, seriousness, severity and relationship of AEs to CC-94676.
• Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 35 days ]
  Number of subjects with a DLT.
• Non-Tolerated Dose (NTD) [ Time Frame: Up to 35 days ]
  The dose of CC-94676 associated with unacceptable safety and tolerability.
• Maximum Tolerated Dose (MTD) [ Time Frame: Up to 35 days ]
  The highest dose of CC-94676 associated with acceptable safety and tolerability.

Current Secondary Outcome Measures (submitted: February 8, 2022)

• Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) [ Time Frame: Up to approximately 4 years ]
• Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) [ Time Frame: Up to approximately 4 years ]
• Duration of response (DOR) [ Time Frame: Up to approximately 4 years ]
• Proportion of participants alive and not progressed at 6 months [ Time Frame: Up to 6 months after treatment is discontinued ]
• PSA Progression Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]
• Radiographic progression free survival (rPFS) [ Time Frame: Up to approximately 4 years ]
• Overall survival (OS) [ Time Frame: Up to approximately 4 years ]
• Overall Survival (OS) rate summarized using the Kaplan-Meier method for the treated population [ Time Frame: Up to approximately 4 years ]
• Pharmacokinetics - Area under the plasma concentration time curve (AUC) [ Time Frame: Up to 35 days ]
• Pharmacokinetics - Maximum plasma concentration (Cmax) [ Time Frame: Up to 35 days ]
• Pharmacokinetics - Time to Cmax (Tmax) [ Time Frame: Up to 35 days ]

Original Secondary Outcome Measures (submitted: June 10, 2020)

• Confirmed Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50) [ Time Frame: Up to approximately 4 years ]
  is defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later (PSA50).
• Objective soft tissue response [ Time Frame: Up to approximately 4 years ]
  The proportion of subjects who achieve a best response of partial response or better (PR or CR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
• Duration of response (DOR) [ Time Frame: Up to approximately 4 years ]
  is defined as the time from the earliest date of documented soft tissue response (PR or CR based on PCWG3) to the first documented soft tissue disease progression or death, whichever occurs first.
• Proportion of subjects alive and not progressed at 6 months [ Time Frame: Up to 6 months after treatment is discontinued ]
  The proportion of subjects alive and who have not progressed at 6 months follow-up with progression defined by PCWG3.
• PSA Progression Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]
  PSA PFS will be calculated for all treated subjects as, after a decline from baseline, the time from the first dose of CC-94676 to the first PSA increase that is ≥ 25% and a ≥ 2 ng/mL above the nadir, and which is confirmed by a second value ≥ 3 weeks later. When there is no decline from baseline, then PSA progression is ≥ 25% increase and a ≥ 2 ng/mL increase from baseline beyond 12 weeks.
• Radiographic progression free survival (rPFS) [ Time Frame: Up to approximately 4 years ]
  The time from the first dose of CC-94676 to the first objective evidence of radiographic progression or death from any cause, whichever occurs first.
• Overall survival (OS) [ Time Frame: Up to approximately 4 years ]
  OS is the time from the first dose of CC-94676 to death from any cause.
• Overall Survival (OS) rate [ Time Frame: Up to approximately 4 years ]
  will be summarized using the Kaplan-Meier method for the treated population.
• Pharmacokinetics - AUC [ Time Frame: Up to 35 days ]
  Area under the plasma concentration time curve
• Pharmacokinetics - Cmax [ Time Frame: Up to 35 days ]
  Maximum plasma concentration
• Pharmacokinetics - Tmax [ Time Frame: Up to 35 days ]
  Time to Cmax
• Pharmacokinetics - t1/2 [ Time Frame: Up to 35 days ]
  Terminal half-life
• Pharmacokinetics - CL/F [ Time Frame: Up to 35 days ]
  Apparent total clearance of the drug from plasma after oral administration
• Pharmacokinetics - Vz/F [ Time Frame: Up to 35 days ]
  Apparent volume of distribution during terminal phase after oral administration

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer
• Official Title: A Phase 1, Multi-center, Open-label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cc-94676 in Subjects With Metastatic Castration-resistant Prostate Cancer
• Brief Summary: The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CC-94676 in men with progressive metastatic castration resistant prostate cancer.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostatic Neoplasms

Intervention

• Drug: CC-94676
  Specified dose on specified days
  Other Name: BMS-986365
• Drug: CC1083611
  Specified dose on specified days
  Other Name: BMS-986409
• Drug: CC1083610
  Specified dose on specified days
  Other Name: BMS-986410

Study Arms

Experimental: Administration of CC-94676, CC1083611, and CC1083610

Interventions:

• Drug: CC-94676
• Drug: CC1083611
• Drug: CC1083610

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 7, 2023): 250
• Original Estimated Enrollment (submitted: June 10, 2020): 40
• Estimated Study Completion Date: December 27, 2026
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Must have histologically or cytologically confirmed adenocarcinoma of the prostate
• Progressed on androgen deprivation therapy (ADT) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (CRPC)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

• Prior treatment with an androgen receptor (AR) degrader
• Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of IP
• Clinically significant venous thromboembolism within 3 months prior to the first dose of IP
• Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness

Other protocol-defined inclusion/exclusion criteria apply

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com; 855-907-3286; Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04428788
• Other Study ID Numbers: CC-94676-PCA-001; U1111-1251-9174 ( Other Identifier: WHO )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: Analytic Code
• Time Frame: See Plan Description
• Access Criteria: See Plan Description
• URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

• Current Responsible Party: Celgene
• Original Responsible Party: Same as current
• Current Study Sponsor: Celgene
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Celgene
• Verification Date: March 2024